The acronym GAMP 5 refers to the Good Automatic Manufacturing Practices, issue 5, document. Although this document has no legal standing and is purely advisory, it does contain information and methodologies that are of interest to anyone engaged in validation activities within the cGMP regulated environment. However; the reality of the situation is that our regulatory requirements for cGMP are published in 21 CFR Part 820/210/211/11 and other government issued edicts.
A company compliant with its regulatory requirements will have written its own equivalent of the GAMP-1/2/3/4/5 series. Only difference is; it will have titled them, Company Regulatory Practices and Procedures (CRPP) (or something similar), and they will be specific to the company.
All the GAMP pertinent documents have been authored by committees, and not everybody in a committee can get their own say. So there is often contentious material, statements and or methods included.
GMP’s should be closely studied and the requirements, as applicable to your company’s activities, should be extrapolated and developed into your quality policies and procedures manual. This manual should then be the definitive authority on all company validation matters.
The GAMP committee has tried to be all things to all people, and in the opinion of many fails to be specific enough to be used as anything other than a discussion document. On the other hand; the work put in to developing your own RPP pays endless dividends, since it documents the responsibilities of all personnel, along with defining the scope of all company qualification processes. It becomes a master reference document and its use ensures that all your company regulatory activities will be compliant with the appropriate regulations.
GAMP 5 Categorization, allows a degree of flexibility when applying validation to the great variety of medical devices, processes, and manufacturing facilities, since it is not possible to state in one document all of the specific validation elements that are applicable. However, a general application of several broad concepts can be used successfully as guidance for validation. These broad concepts provide an acceptable framework for building a comprehensive approach to software validation.
The Guide for Validation of Automated Systems, has been released in December 2001 in Amsterdam. The guide aims to assist companies in the healthcare industries to achieve validated and compliant automated systems.
It provides guidance to the suppliers of those automated systems on their development and maintenance by following good practice, and assists the suppliers in producing the necessary documentation required to support validation.
The guide is a significant advance on previous versions of this widely accepted guidance on validation of automated systems. The complete document has been revisited and refined to reflect current regulatory expectations and good practice. It has been considerably enhanced and restructured, following principles and recommendations defined by the Industry Board.
regulators mandate that all good automated manufacturing processes and methods
used to produce a regulated product must be documented and be company approved. In the majority of cases this requirement is
fulfilled by using standard operating practice documents (SOP’s). The original SOP once approved will reside in
a safe and secure location in change control (this is a regularly audited
really depends on your company practices and procedure (which also must be
documented and approved) as to whether the SOP is in electronic format with; or
without, e signatures. Security of this
document is initially by physical access and then by a series of cascading
passwords. The cascade must ensure that
the person accessing the document can only access the document to the level
that the company has authorized. Continuous control of all issued copies must
be maintained by change control.
control must at all times (another regularly audited point) know the location
of all the SOP copies in circulation and must have the capability to be able to
recall them for incorporation of amendments or destruction.
As an auditor I have audited for these features for many years, I have never found a case of un-authorised SOP changes. I have found many cases where the operators failed to follow the SOP. This always puzzles me; why shoot your self in the foot over something so obvious, but a glance through the warning letters shows this is still one of the major causes of FDA citations.
This Corporate Validation Manual (CVM) is supplied loaded to a memory stick (MS) and complete with the attachments that are listed in the graphics below. These high quality documents and protocols are all constructed in Microsoft Word. Each document is preceded by an SOP which prompts you through the procedure of populating and then customizing the template, into your own bespoke company document. This MS has real documents, detailed, compliant and interactive, but most of all - Highly Cost Effective. These documents have evolved through over thirty years of joint validation expertise, they will free up a lot of your time and enable you to deliver your validation projects and tasks on time.
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combination protocol has been produced in response to several hundred reader
suggestions we received in our ‘Suggestions Section’. It has been carefully
designed to make it the preferred choice for Process and Laboratory stand alone
equipment. It is interactive, easy to use and suitable for all mixes of
equipment with and without software.
The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.
Package -- $499.00
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique but also highly cost-effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.